25 mg, 50 mg, 100 mg, 200 mg, film-coated tablets
topiramate
What Topiramate Actavis is and what it is used for
Topiramate Actavis belongs to a group of medicines called antiepileptic medicines.
It is used:
- alone for the treatment of epileptic seizures in adults and children over 6 years of age.
- together with other medicines for the treatment of epileptic seizures in adults and children 2 years and older.
- to prevent migraine headaches in adults.
The topiramate contained in Topiramat Actavis may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Topiramate Actavis
Do not use Topiramate Actavis
- if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).
- Migraine prevention: if you are pregnant or if you are a woman of childbearing age unless you are using an effective contraceptive method (see section “Pregnancy and breast-feeding” for further information). Talk to your doctor about the best method of contraception to use while you are taking Topiramate Actavis.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Actavis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topiramate Actavis if you:
- have kidney problems, especially kidney stones, or receive kidney dialysis
- have had abnormalities in blood or body fluids (metabolic acidosis)
- have liver problems
- have eye problems, especially glaucoma
- have growth problems
- is on a high-fat diet (ketogenic diet)
- taking Topiramate Actavis to treat epilepsy and you are pregnant or a woman of childbearing potential (see Pregnancy and a breast-feeding section for further information)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Actavis.
You mustn’t stop taking your medication without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate, which is given to you as an alternative to Topiramate Actavis.
You may lose weight if you use Topiramate Actavis, so your weight should be checked regularly while using this medicine. If you lose too much weight or if a child using this medicine does not gain enough weight, consult your doctor.
A small number of people who have been treated with anti-epileptic medicines such as Topiramate Actavis have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
Topiramate Actavis can rarely cause high levels of ammonia in the blood (shown in blood tests). This can lead to altered brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. As this can be a serious condition, tell your doctor immediately if you experience the following symptoms (see also section 4 “Possible side effects”):
– have difficulty thinking, remembering information, or solving problems
– is less alert or attentive
– feeling very sleepy with low energy.
At higher doses of Topiramate Actavis, the risk of developing these symptoms may increase.
Other medicines and Topiramate Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate Actavis and some other medicines can affect each other. Sometimes the dose of one of your medicines or Topiramate Actavis needs to be adjusted.
You must especially inform the doctor or pharmacist if you are taking:
- other drugs that impair or impair thinking, concentration, or muscle coordination (e.g. drugs with a depressant effect on the central nervous system such as muscle relaxants and tranquilizers).
- birth control pills. Topiramate Actavis can make your birth control pills less effective. Talk to your doctor about the best method of contraception to use while you are taking Topiramate Actavis.
Tell your doctor if your menstrual bleeding changes while you are taking the pill and Topiramate Actavis.
For a list of all medicines that you take. Show this list to your doctor and pharmacist before starting a new medicine.
Other medicines that you should discuss with your doctor or pharmacist include other medicines for epilepsy, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, valproic acid, St. John’s wort (Hypericum perforatum) (a herbal medicine used to treat depression), blood thinner warfarin.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Actavis.
Topiramate Actavis with food, drink, and alcohol
You can take Topiramate Actavis with or without food. Drink plenty of fluids during the day to prevent kidney stones when you take Topiramate Actavis. You should avoid drinking alcohol while taking Topiramate Actavis.
Pregnancy, breastfeeding, and fertility
Migraine Prevention:
Topiramate Actavis can harm an unborn baby. You must not use Topiramate Actavis if you are pregnant. You must not use Topiramate Actavis for migraine prevention if you are a woman of childbearing age unless you are using an effective method of contraception. Talk to your doctor about which method of contraception is best and if Topiramate Actavis is suitable for you. A pregnancy test must be done before starting treatment with Topiramate Actavis.
Treatment of epilepsy:
If you are a woman of childbearing age, talk to your doctor about other treatment options instead of Topiramate Actavis. If the decision is to use Topiramate Actavis, you must use an effective contraceptive method. Talk to your doctor about the best method of contraception while taking Topiramate Actavis. A pregnancy test must be done before starting treatment with Topiramate Actavis.
Talk to your doctor if you are planning to become pregnant.
As with other medicines against epilepsy, there is a risk of harm to the unborn child if Topiramate Actavis is used during pregnancy. Make sure you fully understand the risks and benefits of using Topiramate Actavis for epilepsy during pregnancy.
- If you take Topiramate Actavis during pregnancy, the baby is at a higher risk of congenital malformations, especially cleft lip and palate. Newborn boys can also have a misshapen penis (hypospadias).
- These malformations can develop early in pregnancy, even before you know you are pregnant.
- If you take Topiramate Actavis during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have any questions about this risk during pregnancy.
- For your condition, there may be other drug treatments that have a lower risk of malformations.
- Tell your doctor immediately if you become pregnant while taking Topiramate Actavis. You and the doctor decide whether you should continue to take Topiramate Actavis during pregnancy.
Breast-feeding
The active substance in Topiramate Actavis (topiramate) is excreted in human breast milk. Effects in breastfed infants of treated mothers have been observed and include diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should refrain from breastfeeding or refrain from treatment with Topiramate Actavis. The doctor will take into account the importance of the medicine for the mother and the risk to the child.
Mothers who are breastfeeding while taking Topiramate Actavis must inform the doctor as soon as possible if the baby experiences anything unusual.
Driving ability and use of machinery
Dizziness, fatigue, and vision problems may occur during treatment with Topiramate Actavis. Do not drive or use any tools or machinery without first talking to your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Topiramate Actavis contains
Topiramate Actavis contains lecithin (soybean oil)
Topiramate Actavis 50 mg, 100 mg, and 200 mg film-coated tablets contain lecithin (soybean oil). If you are allergic to peanuts or soy, do not take this medicine.
Topiramate Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Topiramate Actavis
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- Your doctor will usually let you start with a low dose of Topiramate Actavis and slowly increase the dose until you find the best dose for you.
- Topiramate Actavis tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
- Topiramate Actavis can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones when you take Topiramate Actavis.
If you have used too much Topiramate Actavis
See a doctor immediately. Take the medicine package with you.
You may feel sleepy, tired, or less alert, lack coordination, have difficulty speaking and concentrating, have double or blurred vision, feel dizzy due to low blood pressure, feel depressed or agitated, or have stomach pains or seizures.
Overdose can occur if you take other medicines together with Topiramate Actavis.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Topiramate Actavis
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
If you stop using Topiramate Actavis
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to stop treatment with this medicine, the dose can be gradually reduced over a few days.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or see a doctor immediately if you experience the following side effects:
Very common (may affect more than 1 in 10 users):
- Depression (new or worsening)
Common (may affect up to 1 in 10 users):
- Seizures
- Anxiety, irritability, mood changes, confusion, disorientation
- Difficulty concentrating, impaired thinking, memory loss, memory problems (new, sudden change, or increased severity)
- Kidney stones, frequent or painful urination
Uncommon (may affect up to 1 in 100 users):
- Increased acidity of the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or irregular heartbeat)
- Decreased or lost ability to sweat (especially in young children exposed to high temperatures)
- Have thoughts of serious self-harm, attempt to cause serious self-harm
- Loss of part of the field of vision et
Rare (may affect up to 1 in 1,000 users):
- Glaucoma is a blockage of fluid in the eye and causes increased pressure in the eye, pain, or reduced vision
- Having difficulty thinking, remembering information, or solving problems, being less alert or attentive, and feeling very sleepy with low energy – these symptoms may be a sign of high levels of ammonia in the blood (hyperammonemia) which can lead to altered brain function (hyperammonemia encephalopathy ).
Has been reported (occurring in an unknown number of users):
- Eye inflammation ( uveitis ) with symptoms such as redness in the eye, pain, sensitivity to light, watery eyes, small dots in the field of vision, or blurred vision.
Other side effects include the following. If they get worse, contact your doctor or pharmacist:
Very common (may affect more than 1 in 10 users):
- Stuffy, runny nose, or sore throat
- Tingling, pain, and/or numbness in various body parts
- Drowsiness, fatigue
- Dizziness
- Nausea, diarrhea
- Weight loss
Common (may affect up to 1 in 10 users):
- Anemia (low blood count)
- Allergic reactions (such as skin rash, redness, itching, facial swelling, hives)
- Loss of appetite decreased appetite
- Aggression, excitement, anger, abnormal behavior
- Difficulty falling asleep or staying asleep
- Problems with speech or speech difficulties, slurred speech
- Clumsiness or lack of coordination, feeling unsteady walking
- Decreased ability to complete routine tasks
- Decreased, loss of, or nonexistent sense of taste
- Involuntary tremors or shaking, rapid uncontrolled eye movements
- Visual disturbances such as double vision, blurred vision, reduced visual acuity, difficulty focusing
- Feeling of dizziness ( vertigo ), ringing in the ears, pain in the ears
- Respiratory distress
- Cough
- Nosebleed
- Fever, feeling unwell, weakness
- Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
- Dry mouth
- Hair loss
- Itching
- Joint pain or swelling, muscle cramps or twitching, muscle pain or weakness, chest pain
- Weight gain
Uncommon (may affect up to 1 in 100 users):
- Decreased number of platelets ( blood cells that help stop bleeding), decreased number of white blood cells that help protect you against infection, decreased potassium in the blood
- Increased liver enzymes, increased eosinophils (a type of white blood cell ) in the blood
- Swollen glands in the neck, armpit, or groin
- Increased appetite
- Elevated mood
- Hearing, seeing, or feeling things that are not there, severe mental disorder ( psychosis )
- Not showing and/or feeling emotions, unusual suspiciousness, panic attack
- Reading, speaking, and writing difficulties
- Restlessness, overactivity
- Difficulty thinking reduced alertness or attention
- Reduced or slow body movements, involuntary abnormal or repetitive muscle movements
- Fainting
- Abnormal or reduced sensation
- Impaired, distorted, or no sense of smell
- Unusual feeling or sensation that may precede a migraine or a certain type of attack
- Dry eyes, light sensitivity, involuntary eyelid twitching, watery eyes
- Impaired or lost hearing, loss of hearing in one ear
- Slow or irregular heartbeat, feeling like your heart is pounding in your chest
- Low blood pressure on standing (so some people taking topiramate may feel weak, dizzy, or may faint when standing or sitting up suddenly)
- Redness, feeling of warmth
- Pancreatitis ( inflammation of the pancreas)
- Gas, heartburn, fullness, or bloating
- Bleeding gums, increased salivation, drooling, bad breath
- Intake of abnormally large amounts of fluid, increased thirst
- Discolored skin
- Muscle stiffness, pain in the side
- Blood in the urine, incontinence (lack of control) of urine, urge to urinate, pain in the side or kidney pain
- Difficulty getting or keeping an erection, sexual dysfunction
- Flu-like symptoms
- Cold fingers and toes
- Feeling of intoxication
- Learning problems
Rare (may affect up to 1 in 1,000 users):
- Abnormally elevated mood
- Unconsciousness
- Blindness in one eye, temporary blindness, night blindness
- Visual impairment
- Swelling in and around the eyes
- Numbness, tingling, and discoloration (white, blue, then red) in fingers and toes when exposed to cold
- Liver inflammation, liver failure
- Stevens-Johnson syndrome is a potentially life-threatening condition that may present with ulcers of multiple mucous membranes (eg, mouth, nose, and eyes), skin rash, and blisters
- The abnormal smell on the skin
- Discomfort in arms or legs
- Kidney disease
Has been reported (occurring in an unknown number of users):
- Maculopathy is a disease of the macula, the small spot on the retina where vision is sharpest. You should see a doctor if you notice a change or deterioration in your vision.
- Toxic epidermal necrolysis, a life-threatening condition related to, but more serious than, Stevens-Johnson syndrome, is characterized by widespread blistering and crusting of the outer skin layers (see rare side effects ).
Children
Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults:
- Concentration problems
- Increased acidity in the blood
- Have thoughts of serious self-harm
- Fatigue
- Decreased or increased appetite
- Aggression, abnormal behavior
- Difficulty falling asleep or staying asleep
- The feeling of unsteady gait
- The feeling of not feeling well
- Decreased potassium in the blood
- Not showing and/or feeling emotions
- Watery eyes
- Slow or irregular heartbeats
Other side effects that may occur in children are:
Common (may affect up to 1 in 10 users):
- Dizziness
- Vomiting
- Fever
Uncommon (may affect up to 1 in 100 users):
- Increased eosinophils (a type of white blood cell ) in the blood
- Overactivity
- Feeling of warmth
- Learning problems
How to store Topiramate Actavis
Store out of sight and reach of children.
Use before the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25ºC.
Shelf life after first opening of the can (only plastic can): 100 days.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is topiramate. Each Topiramate Actavis film-coated tablet contains 25 mg, 50 mg, 100 mg, and 200 mg of topiramate.
- Other ingredients are:
Tablet core: mannitol (E421), pregelatinized starch (corn), microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide (anhydrous), magnesium stearate.
Tablet coating:
Topiramate Actavis 25 mg: Opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).
Topiramate Actavis 50 mg: Opadry II 85G32312 yellow (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (soy) (E322), yellow iron oxide (E172).
Topiramate Actavis 100 mg: Opadry II 85G32313 yellow (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, yellow iron oxide (E172), lecithin (soy) (E322)).
Topiramate Actavis 200 mg: Opadry II 85G34776 pink (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (soy) (E322), red iron oxide (E172).
Appearance and package sizes of the medicine
Topiramate Actavis 25 mg: film-coated tablet, white, round, biconvex, 6 mm in diameter, marked with V1.
Topiramate Actavis 50 mg: film-coated tablet, light yellow, round, biconvex, 8 mm in diameter, marked with V3.
Topiramate Actavis 100 mg: film-coated tablet, yellow, round, biconvex, 10 mm in diameter, marked with V4.
Topiramate Actavis 200 mg: film-coated tablet, salmon pink, oval, biconvex, 9.2 x 18.3 mm in size, marked with V5.
Package sizes
Aluminium/aluminium blisters: 7, 10, 14, 20, 56 and 60 film-coated tablets.
HDPE tablet container: 7, 10, 14, 20, 56 and 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavik curve 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria